Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment non-interventional
Sponsor Bristol-Myers Squibb
Start date November 2015
End date October 2019
Trial size 1500 participants
Trial identifier NCT02839629, CA209-319

Summary

A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Scandinavian countries: Denmark, Norway and Sweden Cohort 1 will include all patients with a diagnosis of NSCLC between 2005 and 2013
non-interventional
Patient as data is available (~2010) to 2013
non-interventional

Primary Outcomes

Measure
Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Approximately 2 years
Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Approximately 2 years
Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Approximately 2 years
Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients
time frame: Approximately 2 years
Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Approximately 2 years
Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST)
time frame: Approximately 2 years
Percent of patients with an adverse event (AE)
time frame: Approximately 2 years
Percent of patients with an adverse event (AE)
time frame: Approximately 2 years

Secondary Outcomes

Measure
Body Mass Index (BMI) of NSCLC patients at diagnosis
time frame: At baseline visit
Smoking habits of NSCLC patients at diagnosis
time frame: At baseline visit
Age of NSCLC patients at diagnosis
time frame: At baseline visit
NSCLC clinical subtype of NSCLC patients at diagnosis
time frame: At baseline visit
Tumor node metastasis classification of NSCLC patients at diagnosis
time frame: At baseline visit
Charlson Comorbidity index of NSCLC patients at diagnosis
time frame: At baseline visit
Drug utilization after NSCLC diagnosis by line of therapy
time frame: Approximately 2 years
Proportion of patients who receive surgery by stage at treatment
time frame: Approximately 2 years
Proportion of patients who receive radiation by stage at treatment
time frame: Approximately 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC [NSCLC NOS]) identified in the Cancer registers Exclusion Criteria: - Age under 18 years at time of diagnosis

Additional Information

Official title Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.